RotaTeq

RotaTeq is a vaccine used to help prevent rotavirus infection in infants.

RotaTeq is a vaccine given by mouth and is administered as a 3-dose series to infants between the ages of 6 to 32 weeks.

Common side effects of RotaTeq include diarrhea, vomiting, and fever. 

RotaTeq is an oral vaccine used to help prevent rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4. 

• Merck Sharp & Dohme Corp.

Serious side effects have been reported with RotaTeq. See the "RotaTeq Precautions" section.

Common side effects of RotaTeq include:

• diarrhea
• vomiting
• fever
• runny nose and sore throat
• wheezing or coughing
• ear infection

​This is not a complete list of RotaTeq side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses)

This is not a complete list of RotaTeq drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with RotaTeq including the following:

• Call your child's doctor or go to the emergency department right away if your child has any of the following problems after getting RotaTeq, even if it has been several weeks since the last dose because these may be signs of a serious problem called intussusception (when a part of the intestine gets blocked or twisted):
  • bad vomiting
  • bad diarrhea
  • severe stomach pain
  • blood in the stool
• Allergic reactions, which may be severe and may include:
  • face and mouth swelling
  • difficulty breathing
  • wheezing
  • hives
  • skin rash
• Kawasaki disease. A serious condition that can affect the heart. If not treated, death can occur. Symptoms may include:
  • fever
  • rash
  • red eyes
  • red mouth
  • swollen glands
  • swollen hands and feet

RotaTeq may not fully protect all children that get the vaccine, and if your child already has the virus it will not help them.

Since FDA approval, the spread of vaccine virus to non-vaccinated contacts has been reported. Tell your doctor if you have someone in your household who has a weak immune system, cancer or is taking medications that can weaken the immune system so that your doctor can provide further advice. Hand washing is recommended after diaper changes to help prevent the spread of vaccine virus.

Your child should not receive RotaTeq if:

• He or she had an allergic reaction after getting a dose of this vaccine.
• He or she is allergic to any of the ingredients of the vaccine.
• He or she has Severe Combined Immunodeficiency Disease (SCID).
• He or she has ever had intussusception, a form of blockage of the intestines.

There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq.

Tell your doctor if your child:

• Has illness with fever. A mild fever or cold by itself is not reason to delay taking the vaccine.
• Has diarrhea or has been vomiting.
• Has not been gaining weight or is not growing as expected.
• Has a blood disorder.
• Has any type of cancer.
• Has a weak immune system because of a disease (this includes HIV/AIDS).
• Gets treatment or takes medicines that may weaken the immune system (such as high doses of steroids) or has received a blood transfusion or blood products within the past 42 days.
• Was born with gastrointestinal problems, or has had a blockage or abdominal surgery.
• Has regular close contact with a member of family or household who has a weak immune system such as someone with cancer or someone taking medicines that weaken their immune system.
• Will be receiving other vaccines.

Tell your doctor about all the medicines your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications and vaccines based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

RotaTeq falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. RotaTeq is not indicated in women of child-bearing age and should not be administered to pregnant females.

Tell your doctor is you are breastfeeding or plan to breastfeed. 

RotaTeq is not indicated in women of child-bearing age and should not be administered to nursing females.

This vaccine will be administered by a healthcare professional.

• Your doctor will gently squeeze the vaccine into your child's mouth. Your infant may spit out some or all of it. If this happens, the dose does not need to be given again during that visit.
• Your child may get RotaTeq at the same time as other childhood vaccines
• All 3 doses of the vaccine should be given to your child by 32 weeks of age. Your doctor will tell you when your child should come for the follow-up doses. It is important to keep those appointments. If you forget or are not able to go back at the planned time, ask your doctor for advice.

RotaTeq is a vaccine given by mouth. Your child will receive 3 doses of the vaccine.

The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.

RotaTeq is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur in this setting. However, if overdoes is suspected, seek emergency medical attention.